Date: August 10, 2026 PMID: 42573944 Category: N/A Authors: Kai Chen, Yixuan Zhao, Kentaro Takeda, Ying Yuan Abstract: The US Food and Drug Administration (FDA) launched Project Optimus and issued guidance to reform dose-finding and selection trials, shifting the paradigm from identifying the maximum tolerated dose (MTD) to determining the optimal biological dose (OBD), which optimizes the risk and benefit of treatments. The FDA's guidance emphasizes the importance of co

Date: August 22, 2025 PMID: PMC12240483 Category: N/A Authors: Yixuan Zhao, Rachael Liu, Jianchang Lin, Ying Yuan Abstract: 40626646 One common approach for dose optimization is a two-stage design, which initially conducts dose escalation to identify the maximum tolerated dose, followed by a randomization stage where patients are assigned to two or more doses to further assess and compare their risk-benefit profiles to identify the optimal dose. A limitation of this approach